Janssen’s Tecvayli (teclistamab) Receives EC’s Conditional Marketing Authorization for Multiple Myeloma


The EC has granted CMA of Tecvayli as monothx. for r/r MM who received 3 prior therapies incl. an immunomodulatory agent, a proteasome inhibitor & an anti-CD38 Ab
The CMA was based on the P-I/II (MajesTEC-1) study evaluating teclistamab in 165 adult patients which showed that 104 patients achieved an ORR (63%) after a median of 5 prior lines of therapy; VGPR (58.8%); CR (39.4%); median time to 1st confirmed response was 1.2mos. and m-DoR (18.4mos.) & also showed deep & durable responses, m-PFS (11.3mos.) & m-OS (18.3mos.)
The therapy is being studied in multiple monothx. & combination studies. Under the license agreement with Janssen, OmniAb will receive $10M in milestones at 1st commercial sale of teclistamab in the UK, Italy, Germany, France, or Spain

Ref: Johnson & Johnson | Image: Johnson & Johnson